VALLEMENT FLEX- lidocaine/menthol patch

Country: United States

Language: English

Source: NLM (National Library of Medicine)

Active ingredient:

MENTHOL (UNII: L7T10EIP3A) (MENTHOL - UNII:L7T10EIP3A), LIDOCAINE (UNII: 98PI200987) (LIDOCAINE - UNII:98PI200987)

Available from:

PLUM VALLEY PHARMA LLC

Administration route:

TOPICAL

Prescription type:

OTC DRUG

Therapeutic indications:

Purpose Topical Anesthetic Uses: For the temporary relief of pain Do not use - more than 1 patch on your body at a time or on cut, iritated or swollen skin - on puncture wounds - for more than 1 week without consulting a doctor Stop use and ask a doctor if - condition worsens - redness is present - irritation developes - symptoms persist for more than 7 days or clear up and occur again within a few days. - you experience signs of skin injury, such as pain, swelling, or blistering where the product was applied.

Authorization status:

unapproved drug other

Summary of Product characteristics

VALLEMENT FLEX- LIDOCAINE/MENTHOL PATCH
PLUM VALLEY PHARMA LLC
_Disclaimer: This drug has not been found by FDA to be safe and
effective, and this_
_labeling has not been approved by FDA. For further information about
unapproved_
_drugs, click here._
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VALLEMENT
_DRUG FACTS_
_ACTIVE INGREDIENTS_
Lidocaine HCL 4%
Menthol 4%
_PURPOSE_
Topical Anesthetic
_USES:_ For the temporary relief of pain
_WARNINGS:_
FOR EXTERNAL USE
DO NOT USE
more than 1 patch on your body at a time or on cut, iritated or
swollen skin
on puncture wounds
for more than 1 week without consulting a doctor
WHEN USING THIS PRODUCT
use only as directed. Read and follow all directions and warnings on
this label.
rare cases of serious burns have been reported with products of this
type
do not apply to wounds or damaged, broken or irritated skin
do not allow contact with the eyes and mucous membranes
do not bandage tightly or apply local heat (such as heating pads) to
the area of use
do not use at the same time as other topical analgesics
dispose of used patch in manner that always keeps product away from
children and
pets. Used patches still contain the drug product that can produce
serious adverse
effects if a child or pet chews or ingests this patch.
STOP USE AND ASK A DOCTOR IF
condition worsens
redness is present
irritation developes
symptoms persist for more than 7 days or clear up and occur again
within a few
days.
you experience signs of skin injury, such as pain, swelling, or
blistering where the
product was applied.
IF PREGNANT OR BREAST-FEEDING, ASK A HEALTH CARE PROFESSIONAL BEFORE
USE.
KEEP OUT OF REACH OF CHILDREN AND PETS. If swallowed, get medical help
or contact a
Poison Control Center right away.
_DIRECTIONS_
ADULTS AND CHILDREN OVER 12 YEARS: Clean and dry the affected area
Open pouch and remove one patch
Remove the protective film from the patch and apply patch to the
affected area
Reseal pouch containing unused patches after each use
Use 1 patch for up to 12 hours
CHILDREN 12 YEARS OR YOUNGER: ask a doctor
_OTHER INFORMAT